System for securing a suture

ABSTRACT

A system is disclosed for securing a suture. The system includes a deformable suture clip having a pair of closely spaced panels configured for movement between an open position wherein a suture can pass between the two panels and a closed position wherein the suture can be securely clamped between the two panels. The system further includes a clip applicator having an elongated body defining opposed proximal and distal end portions. The distal end portion of the body includes a mounting fixture having structure for supporting the suture clip in an open position. The clip applicator further includes a mechanism for dislodging the suture clip from the mounting fixture, such that the panels of the clip move to the closed position to securely clamp the suture therebetween.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.10/930,161 filed 31 Aug., 2004, which is incorporated by referenceherein in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The subject disclosure relates to a system for securing a suture, andmore particularly, to a surgical apparatus for applying a deformablesuture clip to a suture used to close a surgical incision or woundformed in a blood vessel or body tissue.

2. Background of the Related Art

Sutures have long been used to close wounds and surgical incisions inbody tissue. It is common practice to secure a suture in body tissue bytying one or more knots therein. Knots are time consuming to tie,difficult to form in small body cavities and are a relatively unreliablemeans of securely maintaining a suture in tissue. In view of theseshortcomings, various devices and fasteners have been developed topositively secure a suture in place following a surgical procedure.

For example, U.S. Pat. No. 6,077,277 to Mollenauer et al. discloses adevice for joining suture segments together. The device has a pair ofgrasping jaws with heating surfaces thereon configured to weld thesuture together. U.S. Pat. No. 6,086,608 to Ek et al. discloses a suturecollet that consists of an outer member defining a passage for receivinga suture. An inner member is threaded into the outer member to retainthe suture therein. U.S. Pat. No. 5,520,702 to Sauer et al. and U.S.Pat. No. 6,099,553 to Hart et al. each disclose cinches to retain asuture used to close an incision in body tissue.

Certain surgical procedures, such as for example angioplasty procedures,require the creation of a small percutaneous incision or opening in thefemoral artery. Typically, at the conclusion of the procedure, theincision or opening in the blood vessel is closed by applying a fairamount of pressure to the wound until hemostasis occurs. This techniqueis time consuming, uncomfortable and can cause thrombosis, therebypresenting a danger to the patient. Fortunately, surgical instrumentshave been developed to mechanically close incisions in blood vessels,thus avoiding the need for the direct application of pressure to closethe wound.

A particularly useful device for mechanically closing an incision in thewall of a blood vessel following a surgical procedure is disclosed inU.S. Pat. No. 6,454,777 to Green, which is incorporated herein byreference in its entirety. This device applies a suture to the walls ofa blood vessel to close an incision formed therein. Once the suture isplaced and the apparatus is withdrawn from the incision site, a knot isformed in the suture to secure it in place. However, because theprocedure is performed percutaneously through a small entrance wound inthe patient's leg, properly tying a knot to securely fasten the sutureand close the incision is a difficult task. For that matter, placing aclip on the suture at the site of the incision in the blood vessel wallis even more difficult, because there is no direct line of sight toensure the proper placement of the clip.

Clearly, there is a need in the art for an apparatus that is adapted andconfigured to effectively and accurately apply a clip to a suture usedto close an incision formed in the wall of a blood vessel.

SUMMARY OF THE INVENTION

The subject invention is directed to a new and useful system forsecuring a clip to suture used to close a wound or surgical incision inbody tissue, such an opening in a blood vessel. The system includes adeformable suture clip having a pair of closely spaced panels configuredfor movement between an open position wherein a suture can pass betweenthe two panels and a closed position wherein the suture can be securelyclamped between the two panels. The system further includes a clipapplicator having an elongated body defining opposed proximal and distalend portions. The distal end portion of the applicator body includes amounting fixture or lug having means for releasably supporting thedeformable suture clip in an open position. The clip applicator furtherincludes means for dislodging the suture clip from the mounting fixture,such that the panels of the deformable clip move to the closed positionto securely clamp the suture therebetween.

Preferably, the clip applicator further includes means for severing orcutting the suture at a location proximal to the suture clip. Thesevering means is positioned and preferably operates to cut the sutureafter the suture clip is dislodged from the mounting fixture. Themounting fixture is oriented at an angle with respect to thelongitudinal axis of the elongated body of the clip applicator. Thehelps to properly align and position the clip at the incision site, sothat it is flush against the vessel wall or body tissue that has beensutured.

The means for supporting the suture clip in an open position preferablyincludes a clamp block, which extends distally from the mounting fixtureand is dimensioned for insertion between the closely spaced panels ofthe suture clip. The means for dislodging the suture clip from themounting fixture preferably includes an elongated translating pusherfinger adapted to dislodge the suture clip from the clamp block. Themounting fixture preferably includes an opening, which is dimensionedand configured to provide the pusher finger with access to the sutureclip. Preferably, the means for dislodging the clip is manually operablefrom the proximal end portion of the clip applicator.

The subject invention is also directed to a new and useful deformablesuture clip. The suture clip includes a proximal body portion having apair of abutting surfaces configured for movement between an openposition and a normally closed position. In the open position, a suturecan pass between the abutting surfaces. In the normally closed position,the suture can be securely clamped between the pair of abuttingsurfaces. The suture clip further includes a distal body portiondefining, at least in part, deformable means for facilitating themovement of the pair of abutting surfaces between the open and closedpositions.

The proximal body portion of the suture clip preferably includes a pairof closely spaced panels each forming one of the abutting surfaces. Thedeformable means preferably includes, at least in part, a deformablepanel extending generally parallel to the closely spaced panels of theproximal body portion. It is envisioned that at least the deformablepanel of the clip is formed from a metallic material, and preferablyfrom a spring metal or a shape memory alloy. The distal body portion ofthe clip preferably includes a guide notch or slot for receiving thesuture.

The subject invention is also directed to an applicator for applying adeformable clip to a suture used to close an incision or wound in ablood vessel or body tissue. The applicator includes an elongated outertubular body section defining opposed proximal and distal end portions.The distal end portion of the outer body section is truncated andincludes a mounting fixture or lug having means for supporting adeformable suture clip in an open position. The applicator furtherincludes an inner body section cooperatively supported for longitudinaltranslation within the outer body section. The inner body sectionincludes means for dislodging the suture clip supported on the mountingfixture at the distal end of the outer body section, such that thesuture clip moves to a closed position to securely engage the suture ata desired location.

Preferably, the outer body section of the applicator includes a slot foraccommodating the passage of the suture from the incision site to aremote location for access by a surgeon. The mounting fixture or lugpreferably includes a projection or block for maintaining the clip in anopen position. The block fits intimately between the abutting surfacesof the closely spaced panels in the proximal portion of the clip, whichare normally biased into a closed position. The mounting fixture alsoincludes means for aligning the suture clip on the distal end of theapplicator. The aligning means preferably includes a plurality of stopsor tabs, which project from the distal surface of the mounting fixturefor contacting the proximal portion of the clip at predeterminedlocations.

The applicator further comprises means associated with the inner bodysection for cutting the suture at a location proximal to the clip.Preferably, the means for dislodging the suture clip from the mountingfixture includes an elongated pusher finger that extends distally fromthe end of the inner body section. Preferably, means are provided forpreventing rotation of the inner body section with respect to the outerbody section to ensure proper alignment of the pusher finger with thecorresponding aperture in the mounting fixture. Means are also providedfor limiting axial translation of the inner shell assembly relative tothe outer shell assembly. Preferably, the applicator further includesselectively releasable locking means for preventing axial movement ofthe inner body section relative to the outer body section until suchmovement is desired.

The subject invention is also directed to a method for applying a clipto a suture at a desired location. The method includes the steps ofproviding a clip applicator having a deformable clip positioned at adistal end thereof, threading a suture through an opening in thedeformable clip, positioning the deformable clip at a desired locationon the suture, and dislodging the deformable clip from the distal end ofthe applicator in such a manner so that the opening through which thesuture is threaded is closed to securely clamp the suture. The methodfurther includes the step of cutting the suture at a location proximalto the clip.

These and other unique features of the system, apparatus and methoddisclosed herein will become more readily apparent from the followingdescription and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those having ordinary skill in the art to which the subjectinvention appertains will more readily understand how to make and usethe same, reference may be had to the drawings wherein:

FIG. 1 is a perspective view of a clip applicator constructed inaccordance with a preferred embodiment of the subject invention, showingthe novel suture clip dislodged from the lug at the distal end of theapplicator;

FIG. 2 is a perspective view of the clip applicator of FIG. 1 showingthe actuation mechanism associated with the proximal end portion of theclip applicator;

FIG. 3 is an exploded perspective view of the clip applicator of FIG. 1with parts separated for ease of illustration;

FIG. 4 is a localized cross-sectional view as identified in FIG. 1,illustrating the cooperative engagement between the inner and outer bodysections of the clip applicator;

FIG. 5 is a plan view of the lug or mounting fixture disposed on thedistal end of the clip applicator, which includes structure forreleasably supporting the suture clip;

FIG. 6 is a perspective view of a deformable metallic suture clipadapted and configured for use in conjunction with the clip applicatorof FIG. 1, wherein the body of the clip is disposed in a normally closedposition;

FIG. 7 is a perspective view of the suture clip of FIG. 6, viewed fromthe proximal surface, wherein the body of the clip is disposed in adeformed or open position;

FIG. 8 is a perspective view of the suture clip, viewed from the distalsurface, wherein the body of the clip is disposed in an open position;

FIG. 9 is a plan view of the distal end of the clip applicator of FIG.1, with the surgical clip of FIG. 6 supported on the mounting fixture inan open position;

FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. 9,illustrating the manner in which the mounting structures on the lugengage the suture clip;

FIG. 11 illustrates the advancement of the clip applicator to the siteof an incision in the wall of a blood vessel, with the suture to whichthe clip is to be applied threaded through the clip and a slot in thedistal end of the applicator;

FIG. 12 illustrates the movement of the safety lock-out mechanism from alocked position to an unlocked position so the clip applicator may befired;

FIG. 13 illustrates the distal advancement of the inner body sectionrelative to the outer body section to effectuate the dislodgment of theclip from the mounting fixture at the distal end of the applicator;

FIG. 14 illustrates the manner in which the pusher finger at the distalend of the inner body section dislodges or ejects the clip from themounting fixture at the distal end of the outer body section, as thecutting blade simultaneously severs the suture; and

FIG. 15 illustrates the withdrawal of the clip applicator from the siteof the incision after the clip has been dislodged from the mountingfixture and the suture has been cut at a location proximal to the clip.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to the drawings wherein like reference numerals identifysimilar structural elements of the apparatus disclosed herein, there isillustrated in FIG. 1 a suture clip applicator constructed in accordancewith a preferred embodiment of the subject invention and designatedgenerally by reference numeral 100. In the specification that followsthe term “distal” shall refer to the end of the applicator that isnearest to the surgical site, while the term “proximal” shall refer tothe end of the applicator that is farthest from the surgical site.

Referring to FIGS. 1 and 2, clip applicator 100 is adapted andconfigured to apply or otherwise secure a deformable suture clip 102 toa suture at a desired location, to secure the suture in place and ensureeffective wound closure. It is envisioned that the clip applicator 100of the subject invention may be employed in conjunction with apercutaneous procedure, for example, to secure a suture used to close anopening in a blood vessel, or it may be employed in conjunction with aconventional open surgical procedure, for example, to secure a sutureused to close an incision or wound in body tissue.

With continuing reference to FIGS. 1 and 2, clip applicator 100 includesan outer tubular body section 106, which has an outer diameter of aboutbetween 5 mm to 10 mm or more, depending upon the application in whichthe device is employed. The outer body section 106 is adapted andconfigured to slideably receive and accommodate an inner tubular bodysection 108 of lesser outer diameter. A mounting fixture or lug 110mounts on the truncated distal end portion 112 of the outer body section106 for releasably retaining or otherwise supporting the noveldeformable suture clip 102 of the subject invention. In operation, theinner body section 108 is adapted and configured for translation withinthe outer body section 106 to dislodge the clip 102 from the mountingfixture or lug 110. A safety lockout mechanism 114, which will bediscussed in greater detail below, is operatively associated with theproximal end portion of clip applicator 100 to prevent the applicatorfrom being fired until such action is desired. In use, this lockoutmechanism prevents the undesired relative movement of the inner andouter body sections, so that the clip cannot be dislodged from the lug.

Referring now to FIG. 3, the outer body section 106 of clip applicator100 has an elongated tubular housing 118 with a truncated distal endportion 112, as mentioned above. A mounting fixture or lug 110 isdisposed at the distal end portion 112 of the housing 118. The lug 110may be integrally formed or molded with the housing 118, or it may beglued and/or press fit thereto as would be appreciated by those ofordinary skill in the art. Preferably, the lug 110 is angled withrespect to the longitudinal axis formed by the housing 118, to ensureproper alignment and placement of the clip relative to a blood vesselduring a percutaneous procedure in which the instrument is typicallyoriented at an angle to the blood vessel.

Referring to FIG. 5, the mounting fixture or lug 110 is generallyoval-shaped in order to complimentarily engage the truncated distal endportion 112 of the tubular housing 118. The lug 110 defines a centralslot 120 for allowing a surgeon to thread the suture 104 into thehousing 118 and out of a passage or slot 122 defined in the side wall ofhousing 118 (see FIG. 1). The lug 110 has a distally projecting clampblock 124 provided thereon, adjacent to the central slot 120 forretaining or otherwise supporting the suture clip 102 in an openposition. The clamp block may be formed integral with the lug or joinedthereto in a conventional manner. The lug 110 further includes threeintegrally formed stop blocks or tabs 126 a-126 c that engage the clip102 in predefined locations to align or otherwise maintain the clip 102in a desired orientation on the lug 110. The lug 110 also defines anopening or aperture 128 for allowing an elongated pusher finger 130extending distally from the end of the inner body section 108 to accessthe suture clip 102, and effectuate the dislodgement or ejection of theclip 102 from the lug 110 upon firing the applicator.

Referring again to FIG. 3, the inner body section 108 includes anelongated tubular body 132, which is slideably accommodated within thetubular bore of outer body section 106. The elongated pusher finger 130extends from a distal end portion of tubular body 132 and is dimensionedand positioned to pass through the opening 128 in lug 110 to eject thesuture clip 102 from the distal end of applicator 100. The distal end oftubular body 132 defines a cutting edge or knife blade 134 for severingor cutting the suture 104 disposed in passage 122 of the housing 118, asthe clip 102 is dislodged from the lug 110. It is envisioned that thecutting edge or knife blade 134 may be formed integrally with the end ofthe tubular body 132 or joined thereto in a conventional manner. If theblade 134 is joined to the body 132, it may be formed from a materialthat is dissimilar to the tubular body 132.

With continuing reference to FIG. 3, an end cap 136 is mounted orotherwise disposed at the proximal end portion of tubular body 132. Theend cap 136 has an enlarged outer diameter, relative to the outer bodysection 106, and thus serves to limit the depth of movement of thetubular body 132 within the housing 118. End cap 136 also supports thesafety lockout mechanism 114. The L-shaped lockout mechanism or lockingbracket 114 is slideably mounted within a channel 140 formed in end cap136. The mechanism 114 includes an upper gripping surface 138. A detentor button 147 is formed on the lower surface of the mechanism 114, asbest seen in FIG. 12. The detent 147 cooperates with a recess 145 formedwithin the bottom surface of channel 140 to positively retain themechanism 114 in a locked position. In a locked or engaged position, thelockout mechanism 114 prevents actuation of the clip applicator 100.This locked position is best seen in FIG. 2. In a disengaged or unlockedposition, the lockout mechanism 114 allows actuation of the clipapplicator 100, as best seen in FIG. 12.

Referring now to FIG. 4, the housing 118 of outer body section definesan elongated slot or aperture 142 for receiving a locking projection 144that extends radially outwardly from the tubular body 132 of inner bodysection 108. The cooperative engagement of these structures serves toprevent axial rotation of the inner body section 108 with respect to theouter body section 106. By maintaining the orientation of the inner andouter body sections, the pusher finger 130 remains aligned with theopening 128 in lug 110. Preferably, locking projection 144 is integrallyformed with tubular housing 118. Alternatively, the locking projection144 may be a distinct structure that is selectively mounted to thetubular body 132 after its insertion within the housing 118.

It is envisioned that the components of clip applicator 100 may beformed from a high strength thermoplastic material, such as, forexample, LEXAN®. In such a case, the clip applicator can be treated as adisposable instrument and discarded after use. Alternatively, the clipapplicator of the subject invention may be constructed from stainlesssteel or a similar surgical grade material that may be sterilized in anautoclave after use.

Turning now to FIGS. 6 through 8, the deformable suture clip 102 of thesubject invention is adapted and configured for movement between anormally closed non-deformed position (shown in FIG. 6) and a deformedor flexed open position (shown in FIGS. 7 and 8). In the open or flexedposition, a suture 104 can freely pass through the suture clip 102, asshown for example in FIG. 1. However, in the normally closed position,the suture clip 102 securely clamps the suture 104, as shown for examplein FIG. 15. Preferably, the suture clip 102 of the subject invention isfabricated from a metallic material, such as, for example, a springmetal, a shape memory alloy or the like. It is envisioned however, andwell within the scope of the subject disclosure, that the clip may beformed from a resilient plastic material that can be flexed or bentwithout plastically deforming.

The suture clip 102 is generally rectangular or box-like inconfiguration and includes opposing proximal and distal surfaces orportions 150 and 152, respectively. Sidewalls 154 extend between theproximal surface 150 and the distal surface 152 to form a channel 156through the suture clip 102. The proximal surface 150 has a pair ofclosely space panels 159 that form a seam or opening 158 therebetween toaccommodate a suture. The seam 158 allows the suture clip 102 to spreadopen, as denoted by directional arrows “a”. In the open position, asuture 104 can pass through the seam 158 and the clip can be mounted onthe block 124 of lug 110. Each panel 159 forms an end surface 161 thatabuts the corresponding end surface on the opposing panel 159. In theclosed position of FIG. 6, the abutting surfaces 161 securely clampsuture 104 therebetween. It is envisioned that the abutting surfaces 161can be textured or include a coating to enhance the gripping action onthe suture.

The distal surface portion 152 of clip 102 forms a notch or groove 160that substantially aligns with the central slot 120 of the lug 110 whenthe clip is mounted thereon. The notch 160 allows a surgeon to pass theends of suture 104 through the notch 160 and central slot 120 when thesuture clip 102 is loaded on the clip applicator 100. The distal surfaceportion 152 of the clip defines the portion of the clip that undergoesthe majority of the deformation when the clip is moved to an openposition. This portion of the clip may have a reduced thickness relativeto the remainder of the clip or it may be formed at least in part from amaterial that is different from the remainder of the clip.

To load the suture clip 102 on the mounting fixture or lug 110 at thedistal end of the clip applicator 100, the suture clip 102 is deformedto open the seam 158. The clamp block 124 is positioned between the seam158 and the three stops 126 provide banking surfaces to properlyposition or align the suture clip 102 on the lug 110. At such a time,the abutting surfaces on the panels of the proximal surface portion ofthe clip are compressed against and otherwise intimately engaged withthe clamp block 124. It is envisioned that the suture clip 102 may beloaded onto lug 110 by the surgeon at the time of the procedure, or theclip may be preloaded by the manufacture.

Referring to FIGS. 9 and 10, the suture clip 102 is shown properlymounted or otherwise releasably maintained on the mounting fixture orlug 110 of clip applicator 100. In this instance, the suture clip 102 ispositioned between the three stops 126 to align the seam 158 with theslot 120 in lug 110. The clamp block 124 securely retains the seam 158in an open position at this time, and the proximal surface portion 150of the suture clip 102 is located adjacent to the distal surface of lug110. The notch 160 in the distal surface 152 of the suture clip 102 isalso aligned with the central slot 120 of the lug 110 at this time, sothat the surgeon can readily thread the ends of the suture 104 throughthe notch 160, the open seam 158 and central slot 120 of the lug. Theends of the suture 104 pass out of the clip applicator 100 through thepassage 122 formed in the side wall of housing 118. When a clipapplicator 100 has a suture clip 102 so positioned, the clip applicator100 is loaded and ready to be fired.

Referring now to FIG. 11, in use the clip applicator 100 is initiallyadvanced to the site of an incision in the wall of a blood vessel 170,with the suture 104 to which the clip 102 is to be applied threadedthrough the clip and the slot 122 in the distal end of the applicator.At such a time, there is slack left in the suture. Then the safetylock-out mechanism 114 is moved or slide by the surgeon from the lockedposition (see FIG. 11) to the un-locked position, in the direction ofindicator arrow “b” in FIG. 12.

Thereafter, the suture 104 is pulled tight by the surgeon from a remotelocation to take up any slack. At such a time, the applicator is fired.This is done by effectuating the distal advancement of the inner bodysection 108 into the outer body section 106 in the direction ofindicator arrow “c” in FIG. 13. Upon firing, the pusher finger 130 atthe distal end of the inner body section 108 dislodges or ejects theclip 102 from the mounting fixture 110 at the distal end of the outerbody section 106. Shortly thereafter, the cutting blade 134 severs thesuture 104 proximal to the suture clip 102. Then, as shown in FIG. 15,the clip applicator 100 is withdrawn from the site of the incision 170.

After a period time in which the suture 104 and suture clip 102 haveperformed their usefulness, e.g., hemostasis occurs, the suture clip 102and suture 104 may be removed by deforming the suture clip 102 to theopen position. After removing the suture clip 102, the suture 104 may beremoved for the suture location 170 or, if dissolvable, left in place.

While the subject invention has been described with respect to preferredembodiments, those skilled in the art will readily appreciate thatvarious changes and/or modifications can be made to the inventionwithout departing from the spirit or scope of the invention as definedby the appended claims.

1-14. (canceled)
 15. An applicator for securing a clip to a suturecomprising: a) an outer body section defining opposed proximal anddistal end portions, the distal end portion of the outer body sectionincluding a mounting fixture having means for supporting a deformablesuture clip in an open position; and b) an inner body sectioncooperatively supported within the outer body section, the inner bodysection having means for dislodging the suture clip from the mountingfixture, such that the suture clip moves to a closed position to engagethe suture.
 16. An applicator as recited in claim 15, wherein the outerbody section includes a slot for accommodating passage of the suture toa remote location.
 17. An applicator as recited in claim 15, wherein themounting fixture includes a projection for maintaining the clip in anopen position.
 18. An applicator as recited in claim 15, wherein themounting fixture includes means for aligning the suture clip on thedistal end of the applicator.
 19. An applicator as recited in claim 15,further comprising means associated with the inner body section forcutting the suture.
 20. An applicator as recited in claim 15, whereinthe means for dislodging the suture clip from the mounting fixtureincludes an elongated pusher finger extending from distally from theinner body section.
 21. An applicator as recited in claim 15, furthercomprising means for preventing rotation of the inner body section withrespect to the outer body section.
 22. An applicator as recited in claim15, further comprising means for limiting axial translation of the innerbody section relative to the outer body section.
 23. An applicator asrecited in claim 15, further comprising selectively releasable lockingmeans for preventing axial movement of the inner body section relativeto the outer body section. 24-25. (canceled)